R&D Department, OOO "NPF "Materia Medica Holding", 47-1, Trifonovskaya St., 129272 Moscow, Russia.
Laboratory of Physiologically Active Substances, Federal State Budgetary Scientific Institute of General Pathology and Pathophysiology, 8, Baltiyskaya St., 125315 Moscow, Russia.
Molecules. 2024 Sep 11;29(18):4309. doi: 10.3390/molecules29184309.
A new class of biologics is obtained using the technologically processed of antibodies (TPA), which are used as the initial substance, and their dilution at each stage is accompanied by a controlled external vibrational (mechanical) treatment. This article focuses on the development and validation of a novel technique that can be applied for assessing the identity of TPA-based drugs. It has previously been found that after such treatment, the resulting solution either acquired new properties that were not present in the initial substance or a quantitative change in properties compared to the initial substance was observed. The use of mechanical treatment during the manufacture of the TPA-based drugs can cause the formation of new bonds between the solvent and antibody molecules. These changes manifest themselves in altered adsorption at the surface of the test solutions, which results in the formation of a near-surface film. One of the indicators of such events is the change in the surface temperature of the solution, which can be analyzed using high-resolution thermography. Unlike other methods, the high-resolution thermography allows the near-surface layer of a heterogeneous aqueous solution to be clearly visualized and quantified. A number of experiments were performed: seven replicates of sample preparations were tested; the influence of factors "day" or "operator" was investigated during 12 days of testing by two operators. The method also allowed us to distinguish between technologically processed antibodies and samples containing technologically processed buffer. The thermographic analysis has proven to be a simple, specific, and reproducible technique that can be used to analyze the identity of TPA-based drugs, regardless of the dosage form tested.
一种新的生物制剂是使用抗体的技术加工（TPA）获得的，该技术将抗体作为起始物质，并且在每个阶段的稀释都伴随着受控的外部振动（机械）处理。本文专注于开发和验证一种新的技术，该技术可用于评估 TPA 类药物的身份。此前已经发现，经过这种处理后，所得溶液要么获得了初始物质中不存在的新性质，要么与初始物质相比观察到性质的定量变化。在 TPA 类药物的制造过程中使用机械处理会导致溶剂和抗体分子之间形成新的键。这些变化表现为测试溶液表面吸附的变化，从而形成近表面膜。这种变化的一个指标是溶液表面温度的变化，可以使用高分辨率热成像进行分析。与其他方法不同，高分辨率热成像可以清楚地可视化和量化多相水溶液的近表面层。进行了多项实验：对七个重复的样品制备进行了测试；在由两名操作人员进行的 12 天测试期间，研究了“天”或“操作人员”因素的影响。该方法还允许我们区分技术处理的抗体和含有技术处理缓冲液的样品。热成像分析已被证明是一种简单、特异且可重复的技术，可用于分析 TPA 类药物的身份，而与测试的剂型无关。
